As a key stakeholder for Auvi-Q® (epinephrine injection, USP) who has been interested in updates about the product, I wanted to share the following information.

The agreement between Sanofi and kaléo will terminate later this year. At that time, all U.S. and Canadian rights will be returned to kaléo. Sanofi is in discussions with kaléo on these terms and for an orderly transition plan. Kaléo will evaluate timing and options for bringing Auvi-Q back to market.

This decision aligns with Sanofi’s ongoing transformation to focus on critical therapeutic areas in its global business units. Sanofi US will complete the return and reimbursement process associated with the October 28, 2015 voluntary nationwide product recall of Auvi-Q. For more information on the recall, please visit www.auvi-q.com.

Thank you again for your continued help in informing the community about the recall.

Regards,
Karen Sutherland
U.S. Communications
Sanofi U.S.

Though the rights to market the innovative auto-injector will revert to Kaléo (formally Intelliject) later this year, it remains to be seen whether the device will eventually return to the marketplace.

Despite Sanofi’s press releases, the circumstances surrounding the recall are still shrouded in mystery. It was first reported that a problem was detected in a small number of devices regarding the accurate delivery of the stated dosage of epinephrine, and that the company was recalling all existing devices out of an abundance of caution. Later, the firm acknowledged that some of the devices were under-delivering the stated dose or delivering none at all.

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Despite multiple queries, SnackSafely.com was not able to ascertain the true nature of the recall. Questions regarding how the issue was first discovered, whether the problem was a result of a manufacturing defect or design flaw, how Sanofi performed quality assurance testing, and how many devices were actually affected remain unanswered.

The recall has left American and Canadian consumers with few auto-injector options. There are, however, a number of new, innovative auto-injector designs working their way through the engineering and approval process. You can read about the Windgap device and the Oval device on our blog.